A Phase II Study Of Epirubicin And Thalidomide In Unresectable Or Metastatic Hepatocellular Carcinoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Diagnosis of hepatocellular carcinoma

- Locally unresectable or metastatic disease

- Measurable disease

- No clinically apparent CNS metastases

- No carcinomatous meningitis

PATIENT CHARACTERISTICS:

Age

- Over 18

Performance status

- ECOG 0-2

Life expectancy

- At least 12 weeks

Hematopoietic

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 75,000/mm^3

Hepatic

- SGOT no greater than 5 times upper limit of normal

- Bilirubin no greater than 3.0 mg/dL

- INR no greater than 1.5*

- Albumin at least 2.0 g/dL NOTE: *Not required for patients receiving full
anticoagulation with warfarin for deep vein thrombosis or pulmonary embolism

Renal

- Creatinine no greater than 2.0 mg/dL

Cardiovascular

- No myocardial infarction within the past 6 months

- LVEF normal by echocardiogram or MUGA

Other

- Not pregnant or nursing

- Fertile patients must use effective contraception

- Willing and able to participate in the System for Thalidomide Education and
Prescribing Safety (STEPS) program

- No uncontrolled serious medical or psychiatric illness

- No other concurrent uncontrolled malignancy

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No more than 1 prior chemotherapy regimen for hepatocellular carcinoma

- No prior chemoembolization to the liver

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- More than 2 weeks since prior major surgery